Nxstage System One - Cycler (chronic Application) (2019-10-17)

NxStage System One - Cycler Recall Summary NxStage System One cyclers used for chronic dialysis treatment are being recalled across Canada. The recall is classified as Class I, which indicates a serious safety concern. The specific reason for the recall relates to the device's medical function, though detailed technical information is not provided in this notice.

Reason

Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2019-11-01

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/20d0dd95-ab0d-4644-b0fb-8af4c1148f67